FDA.reportPublic FDA data

NOBILIUM

Primary DI
NPLB130L
Brand
NOBILIUM
Company
CMP INDUSTRIES LLC
Model
NPLB130L
Device description
NOBILDENT POST L B1 / 30L
Published
2017-02-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101029000KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETHHuge Dental Material Co., Ltd.2010-08-16ELM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
NPLB130LPrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Regulatory Flags#

DUNS number
002064319
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M48233010NOBILIUM33012016-11-17
M48233050NOBILIUM33052016-11-17
M48233060NOBILIUM33062016-11-17
M48233070NOBILIUM33072016-11-17
M48233071K0NOBILIUM3307-1K2016-11-17
M48233110NOBILIUM33112016-11-17
M4823311GB0NOBILIUM3311GB2016-11-17
M48233120NOBILIUM33122016-11-17
M48233130NOBILIUM33132016-11-17
M48233140NOBILIUM33142016-11-17
M4823314GB0NOBILIUM3314GB2016-11-17
M48233170NOBILIUM33172016-11-17
M48233190NOBILIUM33192016-11-17
M48234100NOBILIUM34102016-11-17
M48237460NOBILIUM37462016-11-17
M48237470NOBILIUM37472016-11-17
M4823747GB0NOBILIUM3747GB2016-11-17
M48237480NOBILIUM37482016-11-17
M4823748GB0NOBILIUM3748GB2016-11-17
M48237490NOBILIUM37492016-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D0804SNEAZ107ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA40NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25